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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, anti-snoring
510(k) Number K121340
Device Name SOMNODENT G2
Applicant
SOMNOMED INC.
7460 Warren Pkwy Ste 190
Frisco,  TX  75034
Applicant Contact KATHRYN JAYNE
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number872.5570
Classification Product Code
LRK  
Date Received05/03/2012
Decision Date 05/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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